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New treatment option for IBI363 + Chemotherapy
Official title Perioprative Study of IBI363 in Patients With MHC-II-Negative Locally Advanced Gastric Cancer
ClinicalTrials.gov ID: NCT07325630
What this study is testing
What is IBI363 + chemotherapy?
IBI363 + chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ibi363 + chemotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 2 study designed to evaluate the safety and efficacy of IBI363 in combination with oxaliplatin and capecitabine (XELOX) or S-1 and oxaliplatin (SOX) in perioprative treatment of locally advanced MHC-II-negative gastric and gastroesophageal junction adenocarcinoma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients voluntarily enrolled in this study and signed informed consent forms;
- Age 18-75 years;
- Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma;
- MHC-II negative, with \<5% tumour cells displaying staining \<2+ (grade 2 or stronger);
- Clinically staged as cT3-4aN+M0 gastric or gastroesophageal junction adenocarcinoma confirmed by CT and/or laparoscopy (per AJCC 8th Edition staging);
You likely can't join if
- Pregnant or lactating women, or women planning to become pregnant within 6 months prior to, during, or after the last dose of the investigational...
- Known signs of active bleeding from a lesion.
- Patients with known dMMR/MSI-H status.
- Oesophageal or pyloric near-obstruction affecting the subject's ability to eat or gastric emptying, or difficulty swallowing tablets.
- people with unresolved Grade \>1 toxicity related to any prior antineoplastic therapy (excluding persistent Grade 2 alopecia, anaemia, peripheral...
- Known dihydropyrimidine dehydrogenase (DPD) deficiency (or prior fluorouracil-containing therapy resulting in Grade 3 or higher mucositis).
See the full eligibility criteria
- Patients voluntarily enrolled in this study and signed informed consent forms;
- Age 18-75 years;
- Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma;
- MHC-II negative, with \<5% tumour cells displaying staining \<2+ (grade 2 or stronger);
- Clinically staged as cT3-4aN+M0 gastric or gastroesophageal junction adenocarcinoma confirmed by CT and/or laparoscopy (per AJCC 8th Edition staging);
- No prior antineoplastic therapy for current disease (e.g., surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy);
- Scheduled for surgical intervention following completion of neoadjuvant therapy;
- Able to swallow tablets orally;
- ECOG performance status 0-1;
- Expected survival ≥6 months. Key
- Pregnant or lactating women, or women planning to become pregnant within 6 months prior to, during, or after the last dose of the investigational medicinal product.
- Known signs of active bleeding from a lesion.
- Patients with known dMMR/MSI-H status.
- Oesophageal or pyloric near-obstruction affecting the subject's ability to eat or gastric emptying, or difficulty swallowing tablets.
- people with unresolved Grade \>1 toxicity related to any prior antineoplastic therapy (excluding persistent Grade 2 alopecia, anaemia, peripheral neuropathy, electrolyte abnormalities correctable with treatment, or...
- Known dihydropyrimidine dehydrogenase (DPD) deficiency (or prior fluorouracil-containing therapy resulting in Grade 3 or higher mucositis).
- Known hypersensitivity to any monoclonal antibody or component of the chemotherapy agents (capecitabine, oxaliplatin) (resulting in Grade 3 or higher hypersensitivity reaction).
- History of epileptic seizures, active, newly diagnosed, or untreated central nervous system metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal metastases.
- Clinically significant cardiovascular or cerebrovascular disease.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.